Risk Assessment

In 1993, Dr. Alan Hollingsworth started one of the first breast cancer risk assessment programs in the country. As soon as testing for the breast cancer (BRCA) genes became available, he received a $100,000 grant from the Presbyterian Health Foundation (OKC, OK) to establish a model program that was later listed in the first roster of “approved” genetic testing sites nationwide, published by the American Cancer Society. At Mercy Health Center in OKC, Dr. Hollingsworth established yet another approved site for BRCA testing, with the assistance of Sharon Nall, RN, MS, CNS, OCN. In September, 2000, Dr. Hollingsworth published the first lay reference book on the subject, The Truth About Breast Cancer Risk Assessment (with proceeds donated to the Oklahoma Breast Cancer Project). In 2001, he was appointed to the National Risk Assessment Working Group and was asked to serve as the lead author for the group’s first consensus paper.

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Risk Assessment

Risk Stratification with Ductal Fluid Cytology

Risk Reduction Counseling and Treatment

Genetic Counseling and Testing

High Risk Surveillance Program

Dr. Hollingsworth served as Dr. Mark Skolnick’s host in Oklahoma City just months after Skolnick led the team that sequenced the BRCA1 gene. Dr. Skolnick went on to help launch Myriad Genetics, the premier company in genetic testing.
Sharon Nall, RN, MS, OCN, (left) serves as the Women’s Center Clinical Nurse Specialist, coordinating the Risk Assessment and Genetic Testing Programs. Helping in this endeavor is Dr. Hollingsworth’s Administrative Assisstant, Michelle (right).

Risk Assessment is the calculation of a woman’s risk for the development of breast cancer over a defined period of time, and the comparison of that number to the general population. Women without risk factors tend to underestimate their risk, while women with risk factors tend to overestimate. The greatest benefit of risk assessment is providing perspective. Multiple mathematical models are available, but on occasion, they can be very misleading when all the facts are considered. Some risk factors are not included in these models, while protective factors (such as early-age removal of the ovaries) are not included at all. As a result, some women who believe themselves to be at increased risk may actually be below the risk of the general population. Because of Dr. Hollingsworth’s interest in benign breast biopsy results as risk factors for future cancer, all previous breast biopsies are reviewed under the microscope when specific findings are going to impact decision-making. This exercise is unprecedented for risk assessment programs across the country. If these microscopic findings are ‘borderline’, Dr. Hollingsworth asks for the input from Dr. David Page, noted breast pathology expert at Vanderbilt.

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Risk Stratification with Ductal Fluid Cytology

Several methods are available to procure cells from the breast, with the intent being similar to the Pap smear. The difference here is that there is no current method that allows a thorough sampling of the lining of the complex ductal system. Each method has its advantages and disadvantages. The more invasive methods (ductal lavage or random fine needle aspirations) retrieve more cells for study, but have poor patient compliance, limiting the practicality of these approaches. Nipple aspirate fluid retrieves fewer cells, but enjoys a much higher compliance rate.

Regardless of the method used, it should be kept in mind that this approach is not designed as a diagnostic test for breast cancer. The purpose is for risk stratification, part of a risk assessment program that tries to predict probabilities of a future cancer. If you have atypical cells discovered through any of the above methods, your risk for future breast cancer is elevated approximately four-fold. Your risk may be even higher if you have other known risks such as a strong family history.

Dr. Hollingsworth no longer performs ductal lavage or random fine needle aspirations, but arrangements can be made for these studies if you are interested. His focus is on the cytology that is most easily procured through nipple aspirate fluid (NAF), and he currently serves on the Scientific Advisory Board of Neomatrix, Inc., a company based in Irvine, CA that is attempting to improve acceptance of this strategy with their HALO™ device for NAF retrieval. To find out more about the HALO™ Breast Pap Test and where you can have the procedure performed, CLICK HERE.

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Risk Reduction Counseling and Treatment

Risk Reduction Counseling and Treatment is the discussion and therapy that surrounds three general categories of risk reduction: 1) lifestyle/diet, 2) SERM (Selective Estrogen Receptor Modulator) risk reduction, & 3) Surgical Risk Reduction, through oophorectomy (removal of ovaries) and/or preventive mastectomy. Risk reduction is NOT a list of “recommendations,” but rather a dialogue between patient and counselor in a process of discovery for the approach most suited for your personality. Risk reduction with SERMs or surgery should always be a joint decision, made within the framework of the patient’s desires. The delicacy with which a subject such as preventive mastectomy must be handled is why Dr. Hollingsworth believes that risk reduction and genetic counseling is well-managed by a breast disease specialist. Most patient questions are not taxing with regard to complex genetics, but instead bring up difficult issues related to breast cancer management, detection, and prevention. Counseling for (and sometimes prescribing) SERM risk reduction is lengthy and complex, and must be coordinated with the patient’s primary care physician and/or OB-GYN. This complexity persists in counseling surgical options. While preventive mastectomy is often called “mutilating,” it doesn’t have to be that way. Dr. Hollingsworth can introduce you to the wide variety of reconstruction options that are now available.

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Genetic Counseling and Testing

Genetic Counseling and Testing is a natural product of risk assessment, wherein some patients who have a strong family history enter into a program that can involve multiple family members in testing for Hereditary Breast-Ovarian Cancer Syndrome, the result of an alteration in either the BRCA-1 or BRCA-2 gene (or other rare genetic disorders). Women with a strong family history of breast cancer are often surprised that they are unlikely to have alterations in BRCA-1 or BRCA-2 (we use various mathematical models to determine this…different from the models used for general risk assessment). Tip-offs that make a BRCA alteration in the family more likely are early-onset breast cancer in family members, the presence of ovarian cancer at any age, or male breast cancer. A detailed family pedigree is drawn to determine the probability of a BRCA mutation in the patient (as well as her family members) who presents for counseling. Even when patients qualify for testing (by having a probability of BRCA mutation in excess of 10%), many choose NOT to undergo testing for personal reasons after the counseling session is complete. If the process is started in a family, we begin testing with someone who has already developed breast or ovarian cancer in order to document the BRCA alteration in the family. If this person is “normal,” with regard to the BRCA genes, then the process is over for the entire family. If she is “positive,” then many lives can be affected in the family (both men and women). This is a very confusing area where we spend a great deal of time with our patients. Gene testing is a one-time “blood test” that is analyzing the DNA make-up of all the cells in your body with regard to the BRCA genes. Thus, an alteration in the DNA of the white cells of your blood means that every breast cell will have this same (congenital) alteration. Most families with an excess of breast cancers are probably transmitting groups of genes that then interact with the environment – we have no blood test for this ill-defined phenomenon. We are testing for those families where a single mutation in one of the BRCA genes strongly predisposes to breast and ovarian cancer. (All cancers have genetic alterations within the tumor tissue, one example being the HER2-neu gene, but the BRCA mutation is in the “genome,” that is, every cell in the body has the same mutation.). Our consultative sessions often include multiple family members who might be affected by outcomes, and often the decision to enter this process is made by the family as a whole, rather than an individual. BRCA results can dramatically alter our estimated risk for developing breast cancer. For instance, if a woman calculates to be at a 30% lifetime risk for breast cancer, but later is found to be in a BRCA family…her risk for breast cancer may go as high as 85% if she tests positive, or may return to a baseline 10% (general population risk) if she tests negative. For more information on this complex health care option, visit http://www.myriadtests.com/.

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High Risk Surveillance Program

High Risk Surveillance Program is chosen by most women after undergoing risk assessment and includes: digital mammography, frequent clinical exams by Dr. Hollingsworth, the liberal use of ultrasound, and more recently magnetic resonance imaging (MRI). For those women who meet the American Cancer Society guidelines for high-risk screening, we generally follow those recommendations as outlined elsewhere on this web site Breast MRI for High-Risk Screening. However, for all others, two factors determine the specific strategy recommended for you: 1) the degree of density (white) on your mammograms, and 2) your level of risk. (For women at no increased risk and low density mammograms, we do not recommend auxiliary imaging with ultrasound or MRI on a routine basis.)

If your mammograms are considered extremely dense (a “white-out”), the odds of detecting breast cancer at an early stage drop below 50%. In addition, the density itself is a risk factor for breast cancer. Then, if you have additional risks, you still may not meet the threshold of the ACS guidelines, yet in actuality be at a greater risk than some women who do (all this is a function of the weaknesses inherent in the mathematical models). Regardless, with dense mammograms and risk factors, you deserve more than “routine annual mammography.” Our strategies range from adding MRI every 3 years to annual mammograms, all the way to performing MRI yearly and mammography yearly, staggering the two studies at 6-month intervals. Ultrasound is commonly added as well, especially if there are findings on mammography or MRI, but we use it for screening as well, depending on the situation.

In addition to clinical exams performed at the same time as your imaging, we offer the opportunity to participate in our research in developing a screening blood test for the detection of breast cancer. Click here for more information.

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